Dorsey Health Law Blog

The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched the “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Several HHS agencies requested comments and information from the public and have published new or proposed...

Granny Cams Are Likely Here to Stay: Taking Steps to Address the Inevitable

“Granny cams” or family-placed electronic monitoring in a nursing facility have become more commonplace.  Cameras are easier to obtain and set up and can easily be linked to one or more family member’s cell phones.  With COVID visiting restrictions making it more difficult for families to visit their loved ones in person, more and more...

Nursing Facilities and CMPs: The Latest Fight

On January 18, 2021, a lawsuit was filed against the U.S. Department of Health and Human Services (“HHS”) and the Centers for Medicare and Medicaid Services (“CMS”) challenging a CMS policy change dating back to 2017.  The plaintiffs, the National Consumer Voice for Quality Long-Term Care and the California Advocates for Nursing Home Reform, are...

White Papers: Understanding the Final Rules to Revise the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations

In just two weeks, on January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect.  These changes, which are part of the U.S. Department of Health and Human Services (“HHS”) “Regulatory Sprint to Coordinated Care,” are the most significant changes...

Is Data the Next Frontier in ERISA Litigation?

Health and retirement benefit plans subject to the Employee Retirement Income Security Act (“ERISA”) have troves of personal information regarding plan participants and their beneficiaries—e.g., participants’ age, marital status, personal assets, medical and prescription drug claim data, and medical history. Although the Health Insurance Portability & Accountability Act (“HIPAA”) regulates treatment of protected health information,...

Coronavirus Lawsuits Against Healthcare Providers are on the Rise

Among its many impacts, the coronavirus pandemic has already spawned hundreds of employment and health-related lawsuits, with even more litigation likely as businesses continue to bring back workers and increase operations.  Many of these lawsuits have been aimed at employers in the healthcare sector and relate to workplace safety, retaliation, and wrongful termination or wrongful...

The Regulatory Sprint Catches up to HIPAA: New Proposed HIPAA Rules

Today, the Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) issued a Notice of Proposed Rulemaking (“NPRM”) which proposes significant changes to the Health Insurance Portability and Accountability Act (“HIPAA”) and to the Health Information Technology for Economic and Clinical Health Act (“HITECH”) Privacy Rule (the “Privacy Rule”).  The NPRM includes...

OIG Skeptical of Medical Device and Pharmaceutical Speaker Programs

The Department of Health and Human Services Office of Inspector General (“OIG”) has issued a Special Fraud Alert to highlight what it views as inherent risks associated with speaker programs that pharmaceutical and medical device companies organize and fund. These programs are typically company-sponsored events at which one or more physicians or other health care...

Much-Anticipated Final Rules to Revise Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP Regulations Released under “Regulatory Sprint to Coordinated Care”

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their much-anticipated final rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and regulations under the...